DOJ faces ‘capacity’ litigating dietary supplement cases

Trade groups representing manufacturers and retailers of dietary supplement products frequently call on the U.S. Department of Justice to vigorously enforce against “bad actors.”

Last week, during an industry conference in New York, a DOJ trial attorney said his agency is “litigating supplement cases every day of the week, and so we are at capacity in terms of the amount of cases we can take.”

“We develop as many cases as we can,” said Patrick Runkle, who works in the Consumer Protection Branch of DOJ and has litigated high-profile cases involving dietary supplement firms, including a criminal prosecution that brought down USPlabs.

Runkle spoke June 25 during the 12th Annual Legal, Regulatory and Compliance Forum on Dietary Supplements, a two-day event hosted by the American Conference Institute and the Council for Responsible Nutrition.

Runkle emphasized that bringing cases in the dietary supplement sphere is challenging and often involves “deep science,” underscoring the need for clarity.

“My pitch on this topic is essentially that clarity helps everybody,” the DOJ attorney said during a session where he was joined by esquire Miriam Guggenheim of Covington & Burling LLP and Taneesha Routier, director of regulatory affairs with XYMOGEN. “These are very hard cases to prove.”

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Runkle elaborated, “It’s very hard to have judges really understand this stuff when we actually have to go litigate these cases … it behooves industry and regulators to try to provide as much clarity as we can before we’re in court having to put on dueling experts about whether there is a penny’s worth of DMAA in a million dollars equivalent of geranium plants.”

Later in his talk, he reiterated the challenges of targeting criminal behavior.

“It’s actually a much harder proposition than it seems to go and take all the steps necessary to bring that bad actor into compliance or to put that person in prison if that’s something that’s necessary,” Runkle said.

DOJ priorities

Runkle provided a peek into DOJ’s priorities when deciding to bring a criminal case in the supplement space. He said DOJ must take “cases where there are injuries happening.”

In situations where a product is “not causing huge injuries or a clear and present danger,” DOJ must put those cases on the back burner behind ones involving injuries such as liver transplants and emergency room visits, he said.

He also commented on civil injunction referrals from the Food and Drug Administration, noting occasional delays in DOJ’s evaluation of the cases.

“There’s a little bit of a bottleneck there sometimes because … we have to evaluate the case independently and there could be evidentiary issues where we need to go back and get more evidence or do something because we’re going to have to actually bring the case,” Runkle said.

On the issue of criminal referrals, he noted agents across the country with FDA’s Office of Criminal Investigations refer cases to DOJ in Washington, D.C., and to the offices of U.S. attorneys. In deciding whether to bring a criminal case in the supplement industry, Runkle suggested federal prosecutors consider such issues as the amount of litigation risk, “whether the case needs to be brought to vindicate some public interest,” and whether consumers have suffered injuries.

He further noted DOJ has worked on many cases that develop from each other, explaining, “There’s one bad actor who leads to another who leads to another who leads to another.”

Runkle also suggested it’s important to give the FDA additional resources to deal with people who are having difficulty complying.

“That’s the regulator’s job and I know that they’re doing their job, and they work very hard on it every day, but I think the industry has … outpaced all of our abilities to really handle some of what’s going on out there,” Runkle said.

The DOJ lawyer ended his remarks by reiterating that spotting violations is easier than seizing products or bringing a criminal action against a bad actor.

“You walk into sort of a mom-and-pop sports nutrition store anywhere in the country. All of us could spot what’s wrong,” he said.

Runkle added later, “I go to work every morning and I just think, ‘I can’t … dial up some federal agents and go out and seize stuff from some sports nutrition store.’ It seems like I maybe should be able to do that, but I can’t. It’s more complicated than that.”